Volunteering for a Trial

If you make the decision to participate in a research trial, the following will give you an idea of the process and what you can expect.

Pre-Qualification Discussion

Our coordinator will provide you with information about current enrolling studies.  You will be asked for information regarding your medial history to find the right study for you.  If you pre-qualify, our coordinator will review and you will sign an "informed consent" form.  The informed consent details all aspects of the trial that are relevant to your decision to participate in the trial and is the document used to acknowledge your agreement to participate in the trial.   At this time, your screening appointment can be scheduled.

Screening Appointment

During this visit, your medical history will be reviewed and a physical will be performed.  You will be provided with detailed information about the study in which you are planning to participate.  Our doctor and trained clinical research coordinator will oversee your visit and will be available to answer any questions that you have.  If you qualify for the trial, then an enrollment visit will be scheduled.

Enrollment

Upon enrollment, you will be informed of the length of the trial, the expectations of your participation and future appointments.  The duration of the trials varies from one day to several years.

Participation in the Trial

Your participation involves taking the investigational product given to you in accordance with the instructions provided as well as coming to periodic appointments to be evaluated and have tests (such as lab work or x-rays) performed.  Some trials ask you to keep a diary pertaining to the trial.  The safety and well being of a participant is our primary concern.  Your medical information will be closely tracked by our doctors and research coordinator during your visits so that we can monitor your progress.  This information will be provided to the pharmaceutical companies during the trial. 

For most research trials, patients are compensated for the time and travel that is involved in trial participation.  Each trial compensates volunteers differently and amounts will vary.

Should You Participate in Clinical Trials?

Participation in clinical research trials is completely voluntary.  People participate in trials for a variety of reasons:

3.  Participants may hope that the new medical treatment will provide them relief from their symptoms while producing few and/or mild side effects. 

4.  Participants experience a personal benefit from helping in the advancement of medical knowledge.

Patients considering participating in a clinical trial should talk about it with their primary physicians. 

Other Factors to Consider Are . . .

How long will the trial last?

Where is the trial being conducted?

What treatments will be used and how?

What is the main purpose of the trial?

How will patient safety be monitored?

What risks are involved?

What are the possible benefits?

What are the alternative treatments besides the one being tested in the trial?

Can I opt to remain on this treatment, even after termination of the trial?

Patient's Rights, Safety and Privacy

The patient's safety and well-being are the primary concerns throughout a trial.  The patient's rights and safety are protected in two important ways.  First, the conduct of all studies must be approved by an Institutional Review Board.  The review board is responsible for examining the trial's protocol to ensure that the patient's rights, safety and well-being are protected and that the trial does not present an undue or unnecessary risk to the patient.  Second, anyone participating in a clinical trial in the U.S. is required to sign an "informed consent" form which details all aspects of the trial, risks involved and the patient's rights.  Throughout the trial, patients are provided with any new information that becomes available so they can make decisions about their continued participation in the trial.

The patient's privacy is protected at all times.  Although data and information from the trials is shared with pharmaceutical companies, your name and identifying information is confidential and is not provided to any person or organization outside of Alexandria Clinical Research.